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Utility of Th1-cell immune responses for distinguishing active tuberculosis from non-active tuberculosis: A case-control study

机译：Th1细胞免疫应答在区分活动性结核病和非活动性结核病中的效用：病例对照研究

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Currently available Interferon-γ release assay (IGRA) cannot reliably differentiate active TB (ATB) from non-active TB (non-ATB). A study was performed to evaluate the value of Mycobacterium tuberculosis (MTB) specific Th1 cell immune responses which test IFN-γ and IL-2 simultaneous for differentiating ATB from non-ATB. Forty-nine newly diagnosed inpatients with ATB (26 pulmonary TB and 23 extrapulmonary TB) were enrolled as the ATB group. Forty-five volunteers with latent tuberculosis infection (LTBI) and twenty with evidence of previous TB were enrolled during the same period as the non-ATB group. Clinical examination and MTB specific Th1 cell immune responses were performed for all participants. After being stimulated with ESAT-6 and CFP-10, the median frequencies of single IL-2-, single IFN-γ-, and dual IFN-γ/IL-2-secreting T-cells were all higher in the ATB group than in the non-ATB group (20(8–45) vs. 7(3–13), P<0.001;131(44–308) vs. 10(6–27), P<0.001;25(9–74) vs. 7(3–23), P = 0.001, respectively). Evaluation of the diagnostic performance of detecting single IFN-γ-secreting T cells for pulmonary TB employed a cutoff value of 35 iSFCs/250,000 PBMC. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR), and negative likelihood ratio (NLR) were 92.3%, 80.0%, 64.9%, 96.3%, 4.62, and 0.10, respectively. For extrapulmonary TB, using a cutoff value of 23 iSFCs/ 250,000 PBMC, the sensitivity, specificity, PPV, NPV, PLR, and NLR were 91.3%, 76.9%, 58.3%, 96.2%, 3.96, and 0.11, respectively. When combining frequencies and proportion of single IFN-γ-secreting T cells, the test sensitivity was 100% in parallel tests and the specificity was 87.7% in serial tests for pulmonary TB. MTB specific Th1 cell immune responses (FluoroSpot) had value for the differentiation of ATB and non-ATB. Further confirmatory studies are indicated.
机译：当前可用的干扰素-γ释放测定法（IGRA）无法可靠地区分活动性TB（ATB）和非活动性TB（non-ATB）。进行了一项研究，以评估结核分枝杆菌（MTB）特异性Th1细胞免疫反应的价值，该免疫反应同时测试IFN-γ和IL-2区分ATB与非ATB。 ATB组为49例新诊断的ATB住院患者（26例肺结核和23例肺外结核）。与非ATB组在同一时期招募了四十五名患有潜伏性结核感染（LTBI）的志愿者和二十名具有先前结核病证据的志愿者。对所有参与者进行临床检查和MTB特异性Th1细胞免疫应答。在用ESAT-6和CFP-10刺激后，ATB组中单个分泌IL-2-，单个IFN-γ-和双IFN-γ/ IL-2分泌的T细胞的中值频率均高于非ATB组（20（8–45）vs.7（3–13），P <0.001； 131（44–308）vs.10（6–27），P <0.001; 25（9–74） ）vs. 7（3-23），分别为P = 0.001）。使用35 iSFCs / 250,000 PBMC的临界值评估检测单个分泌IFN-γ的T细胞对肺结核的诊断性能。敏感性，特异性，阳性预测值（PPV），阴性预测值（NPV），阳性似然比（PLR）和阴性似然比（NLR）分别为92.3％，80.0％，64.9％，96.3％，4.62和0.10 ， 分别。对于肺外结核，使用23 iSFCs / 250,000 PBMC的临界值，敏感性，特异性，PPV，NPV，PLR和NLR分别为91.3％，76.9％，58.3％，96.2％，3.96和0.11。结合单个分泌IFN-γ的T细胞的频率和比例，在并行测试中，肺结核的测试敏感性为100％，在串行测试中，特异性为87.7％。 MTB特异的Th1细胞免疫应答（FluoroSpot）对于ATB和非ATB的分化具有重要价值。指出了进一步的确认性研究。

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